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Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, and scaphocephalic- shaped heads.

The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.

The provided text describes a 510(k) submission for a medical device called "MyCRO Band," a cranial orthosis used for infants with positional plagiocephaly. However, the document does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested in the prompt.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (STARband®) based on similar indications for use, intended use, basic principles of operation, and basic design, along with non-clinical testing. It mentions "Scanner Evaluation utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility" and "Verification testing included dimensional analysis, fit assessment, and mechanical testing of test samples," but it does not provide:

• A table of specific acceptance criteria and reported device performance values related to clinical outcomes or direct head shape correction metrics.
• Sample sizes for a clinical test set (as the described tests are non-clinical).
• Data provenance (country of origin, retrospective/prospective).
• Information on experts establishing ground truth or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance (as this is a physical orthosis, not an AI/algorithm-based device).
• Type of ground truth used related to clinical efficacy.
• Training set sample size or ground truth establishment for a training set (again, not an AI/algorithm device).

The "Summary of Testing" section lists:

1. Biological evaluation per ISO 10993-1:2018
2. Cytotoxicity testing per ISO 10993-5:2009
3. Irritation and Sensitization testing per ISO 10993-10:2010
4. Scanner evaluation, including repeatability/reproducibility study
5. Verification testing

While these tests "successfully met the predetermined acceptance criteria," the specific criteria and the detailed results demonstrating the device's efficacy in correcting cranial deformities (beyond dimensional accuracy of the scanner or fit of the orthosis) are not provided in this 510(k) summary. These are typically covered in a more detailed study report that is part of the full 510(k) submission but not included in this high-level summary.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and proven device performance based solely on the provided text. The text focuses on the engineering and biocompatibility aspects for demonstrating substantial equivalence rather than a detailed clinical performance study as would be seen for an AI/algorithm device or a device with novel mechanisms of action requiring extensive clinical validation.

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Intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.

The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.

The MyCRO Band is a cranial orthosis intended for infants aged 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic-shaped heads. It works by applying mild pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is also indicated for adjunctive use in infants with surgically corrected synostosis who still have moderate-to-severe cranial deformities.

Because the MyCRO Band functions similarly to the predicate device (Orthomerica Products, Inc., STARband® K180109), the acceptance criteria are based on comparative testing rather than specific performance metrics. The summary provided outlines the types of non-clinical tests conducted and their successful completion, rather than specific numerical acceptance criteria.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test set (e.g., number of test samples for fit assessment, number of scans for scanner evaluation). It refers to "test samples" and "representative simulated cranial shapes."

The data provenance (country of origin, retrospective/prospective) is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described appears to be primarily technical and comparative against established standards or predicate device characteristics, rather than requiring expert adjudication for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

An adjudication method is not mentioned, likely because the tests are technical and objective (e.g., passing a specific ISO standard, dimensional analysis, repeatability metrics).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical cranial orthosis, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as the device is a physical cranial orthosis, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests appears to be:

• Biocompatibility: Established ISO standards (ISO 10993-5:2009, ISO 10993-10:2010).
• Scanner Evaluation: Known dimensions of a "worst-case challenge reference object" and the performance of previously cleared devices.
• Software Validation: Internal device specifications and criteria for interoperability.
• Simulated Cranial Fit Assessment: The fit of manufactured samples to "representative simulated cranial shapes" derived from 3D images.
• Manufacturing Process Validation: Dimensional analysis and mechanical testing, compared to the process used for the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of this physical orthosis does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

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The Tmax wheelchair are suitable for patients with walking impediments/inability due to, but not limited to:

• Palsies/Paralyses .
• Loss of limbs .
• Defective and/or deformed limbs .
• Joint contractures .
• Joint defects .
• Other diseases .

The Discovery Tmax is a manually operated, self/attendant propelled, mechanical wheelchair. It is intended exclusively for the adaptation of orthopedic seating systems (e.g. seating shells) for people who are unable to walk or have walking impediments. The Discovery Tmax can be used indoors and outdoors. In order to provide an optimized, individual fitting, the product is adjustable and/or adaptable.
The Discovery Tmax consists of a non-folding frame of aluminum, large wheels with hand rims, and small front pivoting casters. The width, depth, and height of seat are adjustable in 1 inch increments. The armrest is made of Polyurethane soft integral foam and is adjustable. It also has an adjustable backrest and removable footrest.
The Discovery Tmax includes a "Tilt in space" feature which allows the seat to be tilted. The seat angle can be adjusted from -5° to +50° in increments of 2.5°. The desired seat angle is achieved by moving the push handles/ push bar. The angle can be read from the angle indicator on the hole channel.

This 510(k) summary describes a manual wheelchair, not a software or AI-powered device. Therefore, many of the requested categories related to AI/software performance, such as MRMC studies, standalone algorithm performance, and training/test set details, are not applicable.

Here's the information that can be extracted relevant to the performance of this medical device (a manual wheelchair):

Acceptance Criteria and Device Performance

Study Details:

• Sample size used for the test set and the data provenance: Not applicable in the context of a physical device. The testing was conducted on the device itself.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance against standards is typically established by certified testing laboratories using specified protocols, not expert consensus on medical images or data.
• Adjudication method for the test set: Not applicable. Testing against performance standards for a physical device does not involve adjudication in the sense of expert review of data points.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical non-AI device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical non-AI device.
• The type of ground truth used: Compliance with international and European ISO and DIN EN standards for wheelchairs. This is a form of objective engineering and safety ground truth, verified through physical testing.
• The sample size for the training set: Not applicable. This is a finished physical device, not an AI/software model.
• How the ground truth for the training set was established: Not applicable.

Summary based on provided text:

The Discovery Tmax Manual Wheelchair was tested by TUV SUD, Institute for Testing and Certification of Medical Devices, against a series of international and European standards (DIN EN 12182, DIN EN 12183, and various parts of ISO 7176). The compliance with these standards serves as the "acceptance criteria" and "device performance" proof for this physical medical device. The specific details of the testing (e.g., number of units tested, exact test results against each clause of the standards) are not provided in this 510(k) summary but are typically part of the full submission.

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Provide mobility to persons physically challenged and limited to sitting positions due to:

• Palsies/Paralyses .
• Loss of limbs
• Defective and/or deformed limbs ●
• Joint contractures .
• Joint defects ●
• . Other diseases

The z10 is a powerful push and brake assist for manual wheelchairs. It can also be converted into the z10-ce add-on drive with tiller control quickly and easily. In this product version, the user drives and controls the wheelchair independently.

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

The document is a 510(k) summary for a physical medical device, the "z10 Push and Brake Assist," which is a powered wheelchair mover. The safety testing mentioned refers to physical product standards compliance (e.g., ISO, ANSI/RESNA) for a hardware device, not performance metrics for an AI system.

Therefore, I cannot provide the requested information, as it is not present in the given document.

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The Centro wheelchairs are designed solely for individual use by persons who are unable to walk or who have a walking impediment, and can be operated either by the patient or by another person. Centro wheelchairs are suitable for patients with walking impediments/inability due to, but not limited to:

• . Palsies/Paralyses
• . Defective and/or deformed limbs
• Loss of limb (leg amputation) .
• . Joint contractures/defects
• Diseases such as cardiac or circulatory insufficiency, balance disorders . or cachexia, as well as geriatric patients who still have usable residual strength in the upper limbs.

The Centro Wheelchairs are an uncomplicated line of wheelchair (S1 and A3 models) and are appropriate for short-term use. The Centro wheelchairs are very robust, which ensures that they will have a long service life. The product has a functional knee lever lock. The stable cross brace ensures that it folds easily. Thus, the Gentro can be folded to a very small size easily, and it is convenient to transport or space-saving for storage. The Centro with 124 rear wheels offers the possibility to use it as a functional transit wheelchair. Due to the nylon covering of seat and back upholstery, the chairs are easy to clean or disinfect and thus always quickly ready for use.

The provided document is a 510(k) summary for a manual wheelchair. It describes the device's features, intended use, and the standards it meets. However, it does not contain information about acceptance criteria for an AI/ML device, a study that proves the device meets those criteria, or details regarding the establishment of ground truth by expert readers, multi-reader multi-case studies, or training/test set data specifics.

The document specifically states that the device is a "Manual Wheelchair" and that testing was conducted according to engineering and quality standards for medical devices and wheelchairs (e.g., DIN EN 12182, ISO 7176 series). It also mentions a "field test" to verify suitability for daily use.

Therefore, I cannot fulfill most of your request directly from the provided text, as the questions pertain to the evaluation of an AI/ML-based medical device, which this wheelchair is not.

Here's a breakdown of why I cannot answer each point from the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists various ISO and DIN EN standards the wheelchair complies with (e.g., determination of static stability, brake efficiency, dimensions, static impact/fatigue strengths). These are the "acceptance criteria" for a mechanical device, and the document implicitly states the device "was conducted by Berlin Cert" and "is certified for CE conformity and its suitability for daily use was verified in a field test," implying it met these standards. However, it does not provide numerical performance data like sensitivity/specificity for an AI model.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a mechanical wheelchair. The "test set" would be physical wheelchairs subjected to engineering tests, not data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for a wheelchair's performance is established by direct physical measurements according to standards, not by expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic or interpretative tasks.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this mechanical device, the ground truth is established by the specifications of the DIN EN and ISO standards and direct physical testing against those standards. For example, "determination of static stability" involves specific weight and angle measurements to meet a standard, not a human expert consensus.

8. The sample size for the training set: Not applicable. This device does not use a "training set" in the AI/ML context.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance process for a manual wheelchair, focusing on its compliance with established mechanical engineering and safety standards, not on the performance of an AI/ML diagnostic or assistive device.

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Provide mobility to persons physically challenged and limited to sitting positions.

The Skippi is propelled by two DC Motors, Micro Motor AG PMGST 76/40 L/R 6 Km/H at 24 Volts. The controller is the enAble 40 manufactured by Curtis Instruments, AG. The closed "H" frame is rigid (not foldable), all four wheels are suspended independently. The Skippi has 12.5 inch knobby rear tires. Options available to the end user are the following: Seat Tilt Mechanism, Electric or with Gas Compression Spring. Electric Backrest Angle Adjustment. Seating Shell Adapter. Tray. Control for Attendant. Bumper Bar. Single Panel Footrest. Colors (Yellow, Blue, or Red).

The provided text describes a 510(k) premarket notification for the "Skippi Powered Wheelchair for Children" by Otto Bock Healthcare LP. While it establishes the device's substantial equivalence and general information, it does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, or the methodologies of a specific study to prove those criteria.

Instead, the document states: "The Skippi was tested by TÜV Product Service to the following standards: EN 12184, ISO 7176 -- Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC with the conclusion that 'the test sample fulfills the requirements.'" This indicates compliance with established industry standards but does not provide the specific performance data or study details typically associated with the requested items.

Therefore, I cannot fully complete the requested table and answer all questions based on the provided text.

Here's an analysis of what can be extracted and a clear indication of what is missing:

1. Table of acceptance criteria and the reported device performance:

Missing Information for Table: Specific quantitative or qualitative performance metrics (e.g., speed, battery life, weight capacity, stability angles, turning radius) that would usually define acceptance criteria for a medical device are not provided beyond the general statement of fulfilling requirements of broad standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified. The document refers to "the test sample" (singular), implying at least one wheelchair was tested, but a specific number is not given.
• Data Provenance: Not specified. The testing organization, TÜV Product Service, is a German company, suggesting the testing likely occurred in Europe or by a branch of TÜV, but the country of origin of the data itself is not explicitly stated. It is a prospective test, as it was conducted for the purpose of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This type of information is not applicable to the testing described. The "ground truth" here is compliance with engineering and safety standards, determined through formal testing procedures by a recognized testing body (TÜV Product Service), not through expert clinical consensus or interpretation of medical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This adjudication method is typically used in clinical studies involving multiple expert readers assessing data (e.g., radiological images) to establish a consensus ground truth. The testing for a powered wheelchair's compliance to engineering standards does not involve this methodology.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC comparative effectiveness study is not applicable to this device or the type of testing described. This is a powered wheelchair; its evaluation focuses on safety, performance against engineering standards, and substantial equivalence, not the impact of AI on human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This question pertains to AI/algorithm performance. The device is a physical powered wheelchair, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• The "ground truth" is adherence to established international and national standards for wheelchairs (EN 12184, ISO 7176 -- Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC). These standards define acceptable performance and safety parameters, which are evaluated through specific test procedures.

8. The sample size for the training set:

• Not applicable. This refers to a "training set" used in machine learning or AI development. The Skippi Powered Wheelchair is a physical device, and its evaluation relies on testing against established standards, not on statistical models trained on data.

9. How the ground truth for the training set was established:

• Not applicable. (See point 8).

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The A-200 is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheclchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user opcrating the Penny and Giles (P&G) VSI Electric Wheelchair Control System that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels.

• Provide mobility to persons physically challenged and limited to sitting positions. .

The A-200 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK Health Carc. The A-200 has a closed "U" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.

This submission does not contain information on acceptance criteria and a study proving that the device meets those criteria. Instead, it is a 510(k) summary for the Otto Bock A-200 Powered Wheelchair, focusing on demonstrating substantial equivalence to a legally marketed predicate device (K000739).

The document states that "The A-200 was tested by TÜV Product Service to the following standards: EN 12184, ISO 7176 - Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC with the conclusion that ‘the test sample fulfills the requirements.’" However, it does not explicitly outline the acceptance criteria within these standards or detail the specific results that demonstrate compliance.

Therefore, I cannot provide the requested table or describe a study proving the device meets specific acceptance criteria based on the provided text. The document primarily focuses on regulatory clearance through substantial equivalence, citing adherence to recognized standards as evidence of safety and effectiveness, rather than presenting a detailed performance study with explicit acceptance criteria and results.

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